Regulating Blood Pressure During Recovery from Intracerebral Hemorrhage and Ischemic Stroke
Purpose
The purpose of this research study is to determine whether blood pressure treatment regimens with spironolactone are better than blood pressure treatment regimens without spironolactone at lowering blood pressure in stroke survivors.
Conditions
- Intracerebral Hemorrhage
- Ischemic Stroke
- Spironolactone
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years 2. Symptomatic ICH confirmed by head CT or brain MRI during hospitalization OR ischemic stroke patients. Ischemic stroke will be defined by focal signs/symptoms of any duration associated with evidence of acute arterial infarction on neuroimaging or clinical evidence of cerebral focal arterial ischemic injury with symptoms persisting ≥ 24 hours. 3. Written, informed consent by patient or surrogate 4. Ability to comply with all study procedures and available for the duration of the study
Exclusion Criteria
- Secondary ICH due to trauma, vascular malformation, or tumor 2. Life expectancy < 1 year 3. eGFR <45 4. Serum potassium greater than or equal to the upper limit of normal of the lab on the two most recent consecutive potassium levels prior to enrollment 5. Known hypersensitivity to spironolactone 6. Upper arm greater than 17 inches in circumference 7. Pregnancy, planned pregnancy, or breastfeeding 8. Contraindication to discontinuing mineralocorticoid antagonist therapy for 3-12 months per the investigator's discretion (e.g., refractory proteinuria) 9. Systolic BP >200 mmHg or diastolic BP >110 mmHg at the time of randomization 10. Systolic BP <120 mmHg at the time of randomization 11. Any condition which, in the judgement of the investigator, increases the risk to the patient 12. History of Addison's disease
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Spironolactone |
Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment. |
|
|
No Intervention Standard Care |
Participants randomized to the Standard care arm will be receiving their normal routine blood pressure treatment. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Yale University
Study Contact
Detailed Description
This is a pragmatic, randomized, open-label, blinded-endpoint trial comparing spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens based on the 2017 AHA/ACC guidelines in stroke survivors. This study will randomize a total of 200 patients, 100 white and 100 non-white patients, at least three weeks after last known normal or symptom discovery/onset of their stroke to an antihypertensive regimen with spironolactone once daily or standard BP control based on the 2017 AHA/ACC guidelines for 1 year. Participants will undergo baseline testing for neurohormonal levels and will be followed for 12 months with regular assessment of home BP readings. The primary outcome of home systolic BP will be measured at 3 months.